Dabigatran Impurity 9 CAS 1381757-44-3

Description

Compared with other compounds in its class, the molecular weight of 643.73 g/mol gives Dabigatran Impurity 9 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Dabigatran Impurity 9 (CAS 1381757-44-3) is a certified pharmaceutical impurity reference standard with the molecular formula C34H41N7O6 and a molecular weight of 643.73 g/mol.

The molecular framework of Dabigatran Impurity 9 (C34H41N7O6) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Dabigatran Impurity 9 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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